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| Name | Class |
|---|---|
| Northwell Health | OTHER |
| University of Maryland, Baltimore | OTHER |
| National Institutes of Health (NIH) | NIH |
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In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) on social cognitive impairments in individuals with schizophrenia spectrum disorders. Participants will be chosen by chance to receive either active rTMS stimulation, active iTBS stimulation, sham rTMS, or sham iTBS. The investigators predict that active 10Hz and iTBS stimulation will improve social cognitive impairments compared to sham stimulation. We aim to identify which type of active stimulation is most effective at inducing changes social cognition brain circuitry and secondarily which type of active stimulation is best tolerated and most effective at inducing changes in social cognitive performance.
This study is a randomized, double blind, sham controlled study which aims to use repetitive transcranial magnetic stimulation (rTMS), a form of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with Schizophrenia Spectrum Disorders. We will randomize 60 people with SSDs to three groups: 20 to a conventional form of rTMS (i.e. 10 Hz rTMS); 20 to intermittent theta burst stimulation (iTBS); and 20 to either sham 10Hz rTMS stimulation or sham iTBS. We will determine whether these treatments can change the functional connectivity of key SCog brain circuits by targeting a brain region known as the dorsomedial prefrontal cortex (DMPFC). Since each person's anatomical and functional brain profile is slightly different, we will optimize the orientation and location of coil placement in each individual. Overall, our proposal follows a target engagement framework, including specifics regarding testing brain stimulation parameters (i.e., rTMS vs. iTBS) and individualizing coil placement for optimal targeting. We anticipate that active 10 Hz rTMS or iTBS will demonstrate target engagement compared to sham, and potentially ameliorate SCog deficits in people with SSDs. Our primary goal is to identify which treatment best induces change in SCog brain circuitry and secondarily which treatment is best tolerated and induces changes in social cognitive performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 10 Hz rTMS | Active Comparator | Active treatment will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered at 10 Hz according to conventional FDA-approved parameters (4 s on and 26 s off; 3000 pulses per session; total duration 37.5 mins) . |
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| Active iTBS | Active Comparator | Active iTBS will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered in triplet 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 9 seconds. |
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| Sham rTMS | Sham Comparator | Sham stimulation will be delivered using the same stimulation parameters as either 10 Hz rTMS or iTBS. For both active and sham stimulation, TMS coil positioning for each individual will be optimized by combining participant fMRI data, meta-analytic functional analysis, electric field modelling, and real-time neuronavigation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks. Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mentalizing brain network functional connectivity | Measured using the empathic accuracy fMRI task | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Tolerability | Measured using the Visual Analogue Scale for Pain (VAS) | 2 weeks |
| Treatment Tolerability | Measured using proportion of participants that report headache |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aristotle Voineskos, MD | Centre for Addiction and Mental Health | Principal Investigator |
| Anil Malhotra, MD | The Feinstein Institute for Medical Research, Zucker Hillside Hospital | Principal Investigator |
| Robert Buchanan, MD | Maryland Psychiatric Research Centre, University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Psychiatric Research Centre | Catonsville | Maryland | 21228 | United States | ||
| The Feinstein Institute for Medical Research |
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| Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation) | Device | The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks. Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany) |
|
| Repetitive Transcranial Magnetic Stimulation (Sham) | Device | Other Name: MagPro X100 or R30(Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany) |
|
| 2 weeks |
| Treatment Tolerability | Measured using proportion of participants that report dizziness | 2 weeks |
| Treatment Tolerability | Measured using proportion of treatment related SAE's | 2 weeks |
| Manhasset |
| New York |
| 11030 |
| United States |
| Centre for Addiction and Mental Health | Toronto | Ontario | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2024 | Jun 12, 2024 | 4 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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